Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System

Completed · Not applicable

Conditions studied: Low Vision

In brief

The primary objective is to compare the effectiveness and adverse side-effects of the virtual bioptic telescope and virtual projection screen in a new head-mounted video-based low vision enhancement system (LVES) with a wide field of view to currently employed specifications for head-mounted video display low vision enhancement technology. Secondary objectives are to acquire qualitative information from patients to evaluate the functioning of the system, to optimize system features and operations, and to assess the value patients place on system features, functions, and operating parameters relative to those of current technology. Investigators will conduct a comparative effectiveness study to determine if the novel vision enhancing features of LVES 2 provide low vision patients with benefits superior to those provided by existing technology.

Key facts

Study ID

NCT03728660

Run by

Johns Hopkins University

People needed

88

Starts

2019-01-29

Expected to finish

2021-02-05

Last updated by the study team

2021-02-16

Who can join

Age: 14 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Visual acuity in the better-seeing eye 20/60-20/800
• Horizontal visual field extent >70 degrees diameter, vertical visual field extent >50 degrees.
• Indicate at least 2 goals from the Activity Inventory during the initial screening interview.
• Scores at least 27 in the Telephone Interview Cognitive Status during the initial screening interview

You may not qualify if…

• Patients who are planning ocular surgery (including laser surgery) during the period of study participation or are early in anti-neovascular treatment (<6 injections)
• Younger than 14 years of age
• Unable to participate in a telephone interview
• Indicate less than 2 goals from the Activity Inventory
• Score less than 27 in the Telephone Interview Cognitive Status

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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